NCT02642432CompletedPhase 3
A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
AbbVie0 sites146 target enrollmentStarted: December 7, 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 146
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Study Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
- •Chronic HCV infection
- •Subject must be HCV treatment-naïve or have failed prior HCV treatment
- •Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease
Exclusion Criteria
- •Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
- •HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
- •Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530
Arms & Interventions
ABT-493/ABT-530
Experimental
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Intervention: ABT-493/ABT-530 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time Frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
Secondary Outcomes
- Percentage of Participants With Post-treatment Relapse(From the end of treatment through 12 weeks after the last dose of study drug)
- Percentage of Participants With On-treatment Virologic Failure(Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment)
Investigators
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